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Early Loading of Dental Implants; A Prospective Study in the Mandibular First Molar Area.

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ClinicalTrials.gov Identifier: NCT02836964
Recruitment Status : Unknown
Verified June 2017 by Aladdin Al-Ardah, DDS, MS, Loma Linda University.
Recruitment status was:  Recruiting
First Posted : July 19, 2016
Last Update Posted : June 16, 2017
Sponsor:
Information provided by (Responsible Party):
Aladdin Al-Ardah, DDS, MS, Loma Linda University

Study Description
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Brief Summary:
To evaluate the clinical success, stability, radiographic bone level changes and peri-implants soft tissue parameter of the SLActive surface implant supporting single crowns restorations in early loading in the mandibular first molar region.

Condition or disease Intervention/treatment Phase
Dental Implants Device: Dental Implant Not Applicable

Detailed Description:
The human clinical trial will be designed as a longitudinal prospective study. A total of 24 titanium implants with a modified SLA surface (BLT SLActive®, Institute Straumann AG, Basel, Switzerland) will be placed in the mandibular first molar. 12 for the control group and for the 12 test group.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Early Loading of Dental Implants; A Prospective Study in the Mandibular First
Actual Study Start Date : February 1, 2017
Estimated Primary Completion Date : February 2018
Estimated Study Completion Date : March 2018
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Loading of Dental Implants after 4 weeks

A total of 12 titanium implants with a modified SLA surface (BLT SLActive®, Institute Straumann AG, Basel, Switzerland) will be placed in the mandibular first molar. for this group.

After 4 weeks definitive crown will be placed.

 Device: Dental Implant
Dental implant
Active Comparator: Loading of Dental Implants after 3 months
A total of 12 titanium implants with a modified SLA surface (BLT SLActive®, Institute Straumann AG, Basel, Switzerland) will be placed in the mandibular first molar for this group. After 3 months definitive crown will be placed
 Device: Dental Implant
Dental implant


Outcome Measures
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Primary Outcome Measures :
  1. marginal bone level changes by using periodical radiography. [ Time Frame: assessment of marginal bone level (MBL) will be made at the time of implant placement and after 6 months ]
    Standardized radiographs using customized jig and long cone paralleling technique, using Rinn Film holders (Dentsply, Germany) for assessment of marginal bone level (MBL) will be made at the time of implant placement, as well as at 3 and 6 months 3. Changes in interproximal crestal bone levels will be measured and recorded using NIH Image Program Software(http:/rsb.info.nih.gov/nih-image)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients aged 18 years or older.
  2. Willingness to comply with all study requirements.
  3. Partially edentulous in the in mandibular first molar with presence of the mandibular second molar
  4. Patients of ASA I and ASA II group. No relevant medical conditions such as uncontrolled diabetes mellitus, osteoporosis, malignancies, irradiation and blood dyscrasias.
  5. Free from soft tissue mucosal lesions, caries, and active periodontitis at the time of implant insertion.
  6. Sufficient alveolar bone volume at the implant recipient site at the time of the insertion.
  7. Adequate oral hygiene. Full-mouth plaque score (FMPS) (O'Leary et al. 1972) full-mouth bleeding score (FMBS) (Ainamo & Bay 1975) record as the percentage of surfaces, four per each tooth, patients need to have controlled their periodontal conditions (FMPS 20%, FMBS 20%).

Exclusion Criteria:

  1. Pregnant or lactating females.
  2. Systemic disease likely to compromise implant surgery; uncontrolled diabetes mellitus.
  3. History of irradiation in the head and neck area.
  4. Smoking.
  5. Untreated periodontitis.
  6. Alcohol or drug abuse.
  7. History of Intravenous Bisphosphonate.
  8. Previously augmented or tooth extraction at the intended implant recipient site within the last 6 months.
  9. The use of regenerative procedures in conjunction with implant placement.
  10. Presence of residual roots at the implant recipient site.
  11. Stomatological diseases.
  12. Clinical signs of bruxism.
  13. Initial stability at least 35Ncm
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02836964


Contacts
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Contact: Bader s albader, DDS 9095584983 ext 0000 balbader@llu.edu

Locations
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United States, California
Loma Linda Health Recruiting
Loma Linda, California, United States, 92350
Sponsors and Collaborators
Loma Linda University
Investigators
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Principal Investigator: Aladdin j Alardah, DDS associate professor
More Information
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Responsible Party: Aladdin Al-Ardah, DDS, MS, Principal Investigator, Loma Linda University
ClinicalTrials.gov Identifier: NCT02836964    
Other Study ID Numbers: 5160039
First Posted: July 19, 2016    Key Record Dates
Last Update Posted: June 16, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes